FDA.reportPublic FDA data

NDC 63629-9593-01 - Isosorbide Dinitrate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-9593
Requested NDC
63629-9593-01
Package NDCs from labels
63629-9593-1, 63629-9593-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Isosorbide Dinitrate - Bryant Ranch PrepackBryant Ranch Prepack2024-10-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9593-1Isosorbide Dinitrate100 in 1 BOTTLETABLET100102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9593ISOSORBIDE DINITRATE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20241024_73a1e6c0-71d0-4ba1-bbca-c067479e487d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9593-1EA - Each63629-959391f05d1b-04bc-4358-895d-c8aa61ecd35112023-02-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isosorbide DinitrateISOSORBIDE DINITRATEPar Health USA, LLC6df6a2fa-c56c-4eb6-a485-c16585420eb02026-07-31Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEPar Health USA, LLC3d6164d7-3083-41c5-a6a6-7e144fe29f7d2026-07-22Warnings, Adverse reactionsExact identifier
application number: ANDA211290
ndc (product): 49884-556
rxcui: 197840
spl id: 8c6493ba-15d0-4340-9547-56ed5b6b6d64
spl set id: 3d6164d7-3083-41c5-a6a6-7e144fe29f7d
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATECardinal Health 107, LLC5f585259-59ed-4648-b562-164f3746c8212026-05-19Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEMajor Pharmaceuticals6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb2026-03-13Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEAvPAK0e5842f2-74f6-1f02-01bc-07578bd3b3932026-02-10Warnings, Adverse reactionsExact identifier
unii: IA7306519N
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEREMEDYREPACK INC.829ed058-333f-453c-9f0e-9202e03acf972026-01-08Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEGolden State Medical Supply, Inc.7f860fbd-f130-4652-e053-2991aa0a402e2026-01-08Warnings, Adverse reactionsExact identifier
unii: IA7306519N
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEAdvagen Pharma Ltdb166eb5b-bad8-4663-9c05-1c43539dab2c2026-01-05Warnings, Adverse reactionsExact identifier
rxcui: 197840
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEHikma Pharmaceuticals USA Inc.f0b9b320-0bf8-4342-b654-135ccb6755c22025-12-05Warnings, Adverse reactionsExact identifier
unii: IA7306519N
BiDilHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEAzurity Pharmaceuticals, Inc.e1e63cd5-d1e4-4af5-bad5-1ad41ea46b002025-11-30Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEAmerican Health Packaging5c94ecc0-fcaa-4af3-82c2-ff124f2df3e12025-10-15Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide dinitrateISOSORBIDE DINITRATENorthstar Rx LLC246c749d-aa28-44ce-8d42-984660afff2a2025-08-21Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEIngenus Pharmaceuticals, LLC8f54d5a3-169f-48dd-9250-2c176d2bd9ad2025-06-03Warnings, Adverse reactionsExact identifier
unii: IA7306519N
isosorbide dinitrate and hydralazine hydrochlorideISOSORBIDE DINITRATE AND HYDRALAZINE HYDROCHLORIDEA2A Integrated Pharmaceuticalsae757a78-89e8-4f79-81de-d558db3f72a42025-02-28Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide DinitrateISOSORBIDE DINITRATEBryant Ranch Prepack73a1e6c0-71d0-4ba1-bbca-c067479e487d2024-10-08Warnings, Adverse reactionsExact identifier
application number: ANDA211290
ndc (package): 63629-9593-1
ndc (product): 63629-9593
ndc11 (package): 63629959301
rxcui: 197840
spl id: d39aa53f-52e2-45c6-93de-150f47e14bbf
spl set id: 73a1e6c0-71d0-4ba1-bbca-c067479e487d
unii: IA7306519N
Isosorbide dinitrateISOSORBIDE DINITRATEBluePoint Laboratoriesf1d52e9a-8de1-61db-e053-2a95a90aae502024-09-17Warnings, Adverse reactionsExact identifier
unii: IA7306519N
Isosorbide dinitrateISOSORBIDE DINITRATEZydus Pharmaceuticals (USA) Inc.16818b32-ee5e-4e07-b848-31e892c4b98a2024-08-08Warnings, Adverse reactionsExact identifier
rxcui: 197840
unii: IA7306519N
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEProficient Rx LP1cf9b6dd-9d4e-4ea1-95ae-e9e46a3d1b202024-08-01Warnings, Adverse reactionsExact identifier
unii: IA7306519N
isosorbide dinitrate and hydralazine hydrochlorideHYDRALAZINE HYDROCHLORIDE AND ISOSORBIDE DINITRATEBryant Ranch Prepack2a6fe05a-fcd4-42d1-bf5d-1d39ac2733632024-07-01Warnings, Adverse reactionsExact identifier
unii: IA7306519N
ISOSORBIDE DINITRATEISOSORBIDE DINITRATEProficient Rx LP33d14f59-3ae8-4414-b826-06274cf0f3d92024-07-01Warnings, Adverse reactionsExact identifier
unii: IA7306519N

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.